Food Safety Modernization Act Are You Ready? John Penizotto Executive Director of Business Development International Telematics Bud Rodowick Manager, Fleet Performance Thermo-King March 4, 2014 Food Safety Modernization Act Enacted January 4, 2011 Most expansive changes since 1938 Act Sweeping new FDA powers Proposed Rules are finally being published 1
FSMA Compliance Starts With The key... is that the new law explicitly places primary responsibility for food safety for prevention on food producers and processors, Taylor said. (FDA Deputy Commissioner for Foods, Michael R. Taylor) Why would a fleet ask their customers about FSMA? Compliance requirements identified from the Food Safety Modernization Act require a food producer or processor to perform Hazard Analysis (HACCP) and Hazard Analysis and Risk Based Preventative Controls (HARPC) to ensure that food is not adulterated. From the moment food products are placed into the staging area on the shipping dock until they are unloaded at the receiving dock and stored; that entire process and all aspects of it now should have Hazard Analysis, Preventive Controls, Sanitation, Monitoring, Verification, Recordkeeping, and Corrective Actions written into a Food Safety Plan to be in compliance. Don t be held hostage, be part of the solution. 2
As a refrigerated fleet, understanding how my customers will interpret these proposed rules of FSMA is important. Hazard Analysis and Preventive Controls (Jan 16, 2013) Product Tracing/Recordkeeping for high risk foods (Nov 30, 2013) Sanitary Transportation of Food (Jan 31, 2014) Intentional Adulteration/Food Defense Plan (Dec 20, 2013) The FDA will Publish These Final Rules Preventive Controls for Human and Animal Food Sanitary Transportation of Food August 30, 2015 March 31, 2016 Intentional Adulteration / Food Defense Plan Product Tracing / Record Keeping for high-risk foods May 31, 2016 June 30, 2015 3
Registered Food Facilities Who is impacted? All facilities (any factory, warehouse, or establishment that manufactures, processes, packs or holds food) Your food facility customers Be proactive and have a discussion with them about what their FSMA compliance expectations are. Some food facilities will qualify for specific exemptions. Example: Facilities solely engaged in the storage of packaged food that is not exposed to the environment. Hazard Analysis and Preventive Controls Nonexempt Registered Food Facilities require a written Food Safety plan specific to each covered facility and would be required to include: hazard analysis, preventive controls, monitoring procedures, corrective action procedures, verification procedures and a recall plan. Nonexempt Registered Food Facilities required to have a Food Safety plan are required to make such plan and related records available to the FDA upon written or oral request. 4
Hazard Analysis and Preventive Controls (cont.) The hazard analysis of a food safety plan would be required to include (Only identified the concerns of a fleet.): Transportation practices Storage and distribution Sanitation, including employee hygiene Any other relevant factor The preventive controls of a food safety plan would be required to include (Only identified the concerns of a fleet.): Any other controls necessary an example would be temperature control during transportation of refrigerated goods. Product Tracing Traceability The FDA is required to establish a product tracing system to receive information that improves the capacity to effectively and rapidly track and trace food that is in the United States or offered for import into the United States. The FDA is also required to issue regulations containing new recordkeeping requirements applicable to facilities that manufacture, process, pack, or hold high-risk foods. At the time FDA issues a final rule, the agency is required to publish a list of high-risk foods on its website. The FDA completed two Traceability Pilot Projects. 5
Product Tracing Traceability (cont.) Will the FDA expand requirements for recordkeeping requirements to foods that are not designated as high risk? No. FSMA specifies that additional recordkeeping requirements developed under section 204 must apply only to high risk foods. FDA will be seeking input from stakeholders in considering whether to develop voluntary guidance for foods beyond those designated as high risk to enhance product tracing in the supply chain. Product Tracing Traceability (cont.) Will the FDA recommend certain product tracing technologies either for the pilot or for future regulations and potential guidance? FDA does not plan to recommend specific software or systems at any of these stages. Rather, FDA will focus on the elements of a product tracing system that enable rapid and effective tracing of food products. Under section 204, FDA is not permitted to prescribe specific technologies to maintain records in the context of the additional recordkeeping requirements for high-risk foods. 6
Sanitary Transportation of Food FDA is required to issue regulations on the sanitary transportation of food, as required by Section 111. Quote: If you sell adulterated food r have some role in handling, distributing, or maybe even transporting anywhere along the food chain of that adulterated food, you would be liable to some extent regardless of the cause or origination of the contamination. Dr. David W. K. Acheson stated in an article. Sanitary Food Transportation Proposed Rule The goal of the proposed rule on the sanitary transportation of human and animal food is to prevent practices that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food during transportation. Specifically, the proposed rule would establish requirements for: vehicles and transportation equipment, transportation operations, information exchange, training, records, and waivers. 7
Sanitary Food Transportation Who is Covered With some exceptions, this proposed rule would apply to shippers, receivers, and carriers who transport food in the United States by motor or rail vehicle. It would also apply to a person outside of the United States, such as an exporter, who ships food to the United States in an international freight container by oceangoing vessel or in an air freight container, and arranges for the transfer of the intact container in the United States, if that food will be consumed or distributed in the United States. Intentional Adulteration of Food/Food Defense The FSMA adds a new Section 420 to the FD&C Act. Section 420 requires FDA to conduct a vulnerability assessment of the food system and determine the types of mitigation strategies necessary to protect against intentional adulteration of food. The FDA has concluded that Intentional Adulteration hazards require different controls and plans to address them in a rulemaking on food defense plans. 8
So what do I do now? The Food Safety Modernization Act is evolving. It is important to understand how the compliance requirements will affect your customers and you. Private Fleets visit with their Quality Assurance Department and determine how to help with these new FSMA compliance requirements. For Hire Fleets visit with your Food Facility customers and understand how they intend to be in compliance with these requirements. What do those requirements mean to your fleet? Enforcement of FSMA The food industry leaders The insurance industry The lawyers Consultants will provide assistance FDA once they receive the funding 9
FSMA-Technology Solutions for Food Safety Compliance Quotes The key... is that the new law explicitly places primary responsibility for food safety for prevention on food producers and processors, Taylor said. Food and beverage manufacturers must automate product traceability across the supply chain. In the future, every manufacturer must have complete supplier, manufacturing and delivery data for every product at their finger tips and in real time. (FDA Deputy Commissioner for Foods, Michael R. Taylor) 20 10
FSMA Technology Solutions Data Loggers Strip Chart Temperature Recorders Reefer OEM Microprocessor Integrated Data Recorders GPS Systems with Temperature Probes 1-Way Telematic Solutions that connects to the Reefer micro 2-Way Telematic Solutions that connects to the Reefer micro 1-Way Systems Communication module that installs on the reefer unit and connects directly to reefer OEM microprocessor Modules monitors reefer operating conditions including temperature set point(s), return air temperature, discharge air temperature, door openings, fault/error codes, and majority of reefer conditions coming from the microprocessor. 11
1-Way Systems (cont.) Data is relayed and reported to user subscribers via webbased program Companies have the opportunity to tailor the information they want to see. Reefer alerts, alarms, and reports can be customized by users i.e. when and how they want to be alerted to a situation with the reefer. Reefer fuel level and burn alerting and reporting 2-Way Systems with Remote Control and Command Control from your desk or in the palm of your hand Ability to control and send commands to reefer remotely Start and stop Pre-trip and pre-cool 12
2-Way Systems with Remote Control and Command (cont.) Change set point(s) Change customized preprogrammed settings Clear alarm and fault codes. Initiate defrosts and change defrost settings Temperature Probes Wireless and Hard-Wired Options Can be tethered or mounted to the side walls of the trailer at various points, and or you can use them to probe various food items directly. Wireless probes are mated with the reefer by the serial number through a reader. To move them to another trailer, they must be reprogrammed. 13
Temperature Probes (cont.) Probe alerts can be programmed by the user to provide various conditions involving the temperature readings of the probe. Wired these will most likely be hard-wired in set positions as the temperature information is then relayed to the communication module mounted in the reefer. Wireless- these can be moved throughout the trailer each time the trailer is loaded. The information is transmitted remotely to the module mounted in the reefer. Benefits of Technology Solutions for FSMA Compliance Real-time visibility for product traceability through your chain of custody. Verify pre-cooling Monitor door activity Full data retention and reporting for you and any other entity that requests and or requires information. 14
Benefits of Technology Solutions for FSMA Compliance (cont.) No need to have a human resource physically touch the reefer to get data In the case where you have third party maintenance providers and or Owner/Operators, technology option enables a way to control and monitor the reefer conditions. And to ensure reefer is maintained and working properly. Food Safety Modernization Act Website http://www.fda.gov/food/foodsafety/fsma/defaul t.htm 15
Adjournment Follow the Annual Convention at #2014TCA 2015 Annual Convention Gaylord Palms March 8-11, 2015 16